Status:

COMPLETED

Roux-en-Y Gastric Bypass and Weight Regain

Lead Sponsor:

Washington University School of Medicine

Conditions:

Obesity

Eligibility:

All Genders

21-60 years

Brief Summary

This study compares eating behaviors, meal size, and the size of the gastric pouch and connection between the gastric pouch and small intestine in patients who had gastric bypass surgery two or more y...

Detailed Description

Obesity affects a third of adults in the United States. The most effective treatment for weight loss is bariatric surgery, and the most common surgery performed in the US is Roux-en-Y Gastric Bypass (...

Eligibility Criteria

Inclusion

  • Ages of 21 and 60
  • Laparoscopic RYGB surgery \>2 years before screening
  • Regained \>20% weight from their maximum weight lost after surgery or maintained at least 90% weight loss from the maximum weight loss after surgery

Exclusion

  • Allergy to lidocaine, nut allergies, milk intolerance or any other food allergies/restrictions that are included in our test meals
  • A history of alcohol abuse
  • Currently consuming \>20 gm of alcohol per day
  • Greater than 2 points on the MAST
  • Severe organ dysfunction
  • Anemia (hemoglobin \<10mg/dl)
  • PT, PTT and INR \> 1.5x UNL
  • Triglycerides \> 400
  • LFT \> 2x UNL
  • Women who are pregnant or lactating
  • Participants that smoke greater than 20 pack years
  • Actively using illegal drugs
  • Depression or other psychological disorders that are untreated
  • Diabetics receiving Insulin
  • Patients that have been hospitalized and/or had surgery in the last three months that may be unstable (PI will determine this at Physical Exam)

Key Trial Info

Start Date :

October 1 2015

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2016

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT02302898

Start Date

October 1 2015

End Date

June 1 2016

Last Update

April 9 2018

Active Locations (1)

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1

Washington University School of Medicine

St Louis, Missouri, United States, 63110